Ozempic is a type 2 diabetes medicine, and only that. Its label carries three indications, every one of them in adults with type 2 diabetes: blood-sugar control, the risk of heart attack, stroke and cardiovascular death, and the risk of kidney decline. Weight management is a different brand of the same molecule (Wegovy). This page reads the trials behind those three indications from the current prescribing information (Novo Nordisk, effective 1 June 2026) and their ClinicalTrials.gov records, on 3 October 2026.
How Ozempic's indications line up against Mounjaro's, indication by indication, is on Mounjaro vs Ozempic. This page stays with Ozempic's own record.
The glycaemic record, trial by trial
The label summarises six trials of Ozempic for blood-sugar control. Each compared it with something different, which is what makes the set useful.
| Trial | Weeks | People | Added to | Compared with | HbA1c change, Ozempic arms | HbA1c change, comparator | Reaching HbA1c <7%, Ozempic vs comparator |
|---|---|---|---|---|---|---|---|
| SUSTAIN 1 | 30 | 388 | Diet and exercise alone | Placebo | −1.4 / −1.6 | −0.1 | 73% / 70% vs 28% |
| SUSTAIN 2 | 56 | 1,231 | Metformin and/or a thiazolidinedione | Sitagliptin | −1.3 / −1.5 | −0.7 | 66% / 73% vs 40% |
| SUSTAIN 3 | 56 | 813 | Metformin, ± sulfonylurea | Exenatide ER | −1.4 | −0.9 | 62% vs 40% |
| SUSTAIN 4 | 30 | 1,089 | Metformin, ± sulfonylurea | Insulin glargine | −1.2 / −1.5 | −0.9 | 55% / 66% vs 40% |
| SUSTAIN 5 | 30 | 397 | Basal insulin, ± metformin | Placebo | −1.3 / −1.7 | −0.2 | 56% / 73% vs 13% |
| SUSTAIN FORTE | 40 | 961 | Metformin, ± sulfonylurea | Ozempic's lower arm | −2.1 | −1.9 | 64% vs 56% |
HbA1c in percentage points from baselines of 8.0–8.9%. Where two figures are given they are the trial's two Ozempic arms, as the label reports them. Ozempic prescribing information, section 14.1, Tables 3–8; trial names from each ClinicalTrials.gov record (NCT02054897, NCT01930188, NCT01885208, NCT02128932, NCT02305381, NCT03989232), all completed with results posted.
Three things in the table are easy to miss:
- The comparators were active drugs in four of six trials, and Ozempic's HbA1c fall was larger than each of them — by 0.5 to 0.8 points against sitagliptin and exenatide ER. A drug that only beats placebo has not shown much in type 2 diabetes, where nobody is left untreated.
- The baseline rose as the trials went on. SUSTAIN FORTE enrolled people with a mean HbA1c of 8.8–8.9%, the highest of the set, and recorded the largest falls; a higher starting point leaves more room to fall, so the trials are not a dose-response series.
- Weight fell in every trial on Ozempic, by 3.2 to 6.4 kg, and rose by 0.9 kg on insulin glargine. That is the glycaemic programme's by-product, not its endpoint. Weight results in people without diabetes belong to Wegovy's trials and are on Wegovy vs Ozempic.
The insulin comparison, with the caveat the label states
SUSTAIN 4 is the trial most often cited for "Ozempic beat insulin". The label reports the result and, in the same paragraph, the condition attached to it: the glargine group started on 10 units a day and was titrated toward a fasting glucose target of 71 to under 100 mg/dL, but "only 26% of patients had been titrated to goal by the primary endpoint at week 30, at which time the mean daily insulin dose was 29 U per day." The label accordingly describes the result as a reduction "compared with the insulin glargine titration implemented in this study protocol".
So the comparison is between Ozempic at full trial doses and insulin that, for three people in four, had not finished being adjusted. That does not undo the result — 30 weeks is a normal trial length, and real-world insulin is often under-titrated too — but it is a narrower finding than the headline, and the label says so in its own words. The difference between the two drug types, and what the labels report when they are used together, is on is GLP-1 insulin?.
The heart indication: what SUSTAIN 6 measured
SUSTAIN 6 randomised 3,297 people with type 2 diabetes and cardiovascular disease, kidney disease or risk factors to Ozempic or placebo on top of usual care, for a median of 2.1 years. Its job was to show Ozempic was not harmful to the heart (a non-inferiority margin of 1.3), and it went further:
| Outcome | Placebo (1,649) | Ozempic (1,648) | Hazard ratio (95% CI) |
|---|---|---|---|
| Cardiovascular death, non-fatal heart attack or non-fatal stroke | 146 (8.9%) | 108 (6.6%) | 0.74 (0.58–0.95) |
| Non-fatal heart attack | 64 (3.9%) | 47 (2.9%) | 0.74 (0.51–1.08) |
| Non-fatal stroke | 44 (2.7%) | 27 (1.6%) | 0.61 (0.38–0.99) |
| Cardiovascular death | 46 (2.8%) | 44 (2.7%) | 0.98 (0.65–1.48) |
Ozempic prescribing information, section 14.2, Table 9.
The composite was clearly lower. The parts were not equally so. Non-fatal stroke is the only component whose confidence interval stays below 1, and only just (0.99); the heart-attack interval crosses 1; and cardiovascular deaths were all but identical, 44 against 46. (glp1ledger reading of Table 9.) That is normal for an outcomes trial — they are powered for the composite, not its parts — but it means "Ozempic reduces cardiovascular death" is not what SUSTAIN 6 showed. Its label indication is for reducing the risk of the three-part outcome, in adults with established cardiovascular disease.
The kidney indication: FLOW
FLOW randomised 3,533 adults with type 2 diabetes and chronic kidney disease (mean eGFR 47; 95% already on an ACE inhibitor or ARB) to Ozempic or placebo, followed for a median of 41 months.
| Outcome | Placebo (1,766) | Ozempic (1,767) | Hazard ratio (95% CI) |
|---|---|---|---|
| Kidney composite (≥50% eGFR decline, eGFR <15, dialysis/transplant, renal or CV death) | 410 (23.2%) | 331 (18.7%) | 0.76 (0.66–0.88) |
| ≥50% sustained eGFR decline | 213 (12.1%) | 165 (9.3%) | 0.73 (0.59–0.89) |
| Sustained eGFR <15 | 110 (6.2%) | 92 (5.2%) | 0.80 (0.61–1.06) |
| Chronic dialysis or transplant | 100 (5.7%) | 87 (4.9%) | 0.84 (0.63–1.12) |
| Renal death | 5 | 5 | 0.97 (0.27–3.49) |
| Cardiovascular death | 169 (9.6%) | 123 (7.0%) | 0.71 (0.56–0.89) |
| All-cause death | 279 (15.8%) | 227 (12.8%) | 0.80 (0.67–0.95) |
Ozempic prescribing information, section 14.3, Table 10.
The kidney composite was driven by eGFR decline and by cardiovascular death; the hard kidney-failure end points pointed the same way but did not reach significance on their own, and renal deaths were too few to read. The cardiovascular-death result here differs from SUSTAIN 6's; the two trials enrolled different people (FLOW required chronic kidney disease) and ran for different lengths of time, so the pair is not a contradiction about the drug. The label adds one line most summaries leave out: the benefit "was not evident in patients taking SGLT2 inhibitors at baseline, but there were few events in these patients." Sixteen per cent of FLOW's patients were on one, so whether the two drug classes add up is not settled by this trial.
What changed on the label since 2017
Ozempic's first label, approved in December 2017, carried a Limitations of Use section saying it was "Not recommended as first-line therapy for patients inadequately controlled on diet and exercise", because of "the uncertain relevance of rodent C-cell tumor findings to humans", and that it had not been studied in patients with a history of pancreatitis. The current label has no Limitations of Use section at all. The thyroid C-cell boxed warning remains, and pancreatitis is a warning; what has gone is the label's statement that Ozempic should not be a first choice. (Comparison of the 2017 label on Drugs@FDA with the current DailyMed version.) Where Ozempic sits among diabetes treatments is set by professional guidelines and the prescriber, not by this page; the label no longer rules out first-line use.
Getting it for diabetes
Insurance rules treat a type 2 diabetes prescription and a weight-management prescription differently; how, and where Ozempic falls, is on GLP-1 insurance coverage and the self-pay and savings-card prices, dated, on Ozempic cost. The label's warnings and the side-effect record are on Ozempic side effects, and when a generic semaglutide could arrive on when will Ozempic go generic.
This page reports the label and the trial registry. It is not advice on whether Ozempic suits any person's diabetes; that decision belongs with the prescriber.
Sources
- Novo Nordisk, OZEMPIC (semaglutide) injection, prescribing information, DailyMed set ID adec4fd2-6858-4c99-91d4-531f5f2a2d79, effective 2026-06-01 — sections 1, 5, 14.1 (Tables 3–8), 14.2 (Table 9), 14.3 (Table 10), dailymed.nlm.nih.gov, read 3 October 2026.
- Novo Nordisk, OZEMPIC prescribing information as approved 12/2017 — Highlights and section 1, accessdata.fda.gov, read 3 October 2026.
- ClinicalTrials.gov records NCT02054897 (SUSTAIN 1), NCT01930188 (SUSTAIN 2), NCT01885208 (SUSTAIN 3), NCT02128932 (SUSTAIN 4), NCT02305381 (SUSTAIN 5), NCT03989232 (SUSTAIN FORTE), NCT01720446 (SUSTAIN 6) and NCT03819153 (FLOW) — acronym, status and results-posted flag via the ClinicalTrials.gov API, read 3 October 2026.